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A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Male
Hormone-Refractory Prostate Cancer

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Trial Information

A Multi-Center Phase II Study to Compare MER-101 (20mg) Tablets To Intravenous Zometa 4mg in Male Bisphosphonate-Naive Hormone Refractory Prostate Cancer Patients


Inclusion Criteria:



- Prostate Cancer with rising PSA levels after hormone treatment and bone metastasis
based on an X-ray.

Exclusion Criteria:

- Already be on a bisphosphonate treatment (Zometa, Fosamax, Actonel)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effects on 4 markers of bone metabolism

Outcome Time Frame:

Weekly

Safety Issue:

No

Principal Investigator

Thomas W Leonard, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Merrion Pharmaceuticals, LLC

Authority:

United States: Food and Drug Administration

Study ID:

MER-101-03

NCT ID:

NCT00636740

Start Date:

February 2008

Completion Date:

February 2009

Related Keywords:

  • Hormone-Refractory Prostate Cancer
  • Prostate cancer, hormone resistant, bisphosphonate
  • Prostatic Neoplasms

Name

Location

Innovative Medical Research of South Florida, Inc.Miami, Florida  33138
Lakeland Regional Cancer CenterLakeland, Florida  33805
Birmingham Hematology & Oncology Associates, LLCBirmingham, Alabama  35223
Charleston Hematology Oncology Associates, PACharleston, South Carolina  29403
Cancer Outreach Associates, P.C.Abingdon, Virginia  24211
Cancer Care of North Florida, P.A.Lake City, Florida  32055
Green Clinic, LLCRuston, Louisiana  71270
New York Urological Associates, PCNew York, New York  10022